BURTON HEARINGS ARE A TURNING POINT

A CANCER CHRONICLES EDITORIAL

© 1998 by Ralph W. Moss, Ph.D.

The following editorial was written in the heat of the moment, immediately following the first Burton hearings. Within weeks--as I predict at the end of this editorial-- big changes began to occur at the National Cancer Institute, including the decision of Director Klausner to "pull" the derogatory NCI statements on alternative and complementary treatments.

Obviously, my evaluation of Dr. Klausner has changed since this editorial was written. As I now see it, Dr. Klausner should be praised for his moral courage and leadership. (See my Letter to Colleagues.) However, I have retained this editorial here, if only for its historical relevance.

We expect further announcements soon on measures being taken to implement the POMES Process. Clearly, the struggle is far from over. In a sense it is only beginning. But we have seen the voices of reason asserting themselves at NCI. This is not a victory "over" NCI, but a victory for all of us, NCI included. --RWM, 2/26/98


The Hearings held on February 4th, 1998 before the Committee on Government Reform and Oversight were a turning point for the cause of medical freedom of choice. They brought defenders of such methods face-to-face with members of Congress, some of whom are themselves fighting cancer. Not only was the role of the Food and Drug Administration (FDA) dramatically exposed, and practical reform proposals put forward, but the negative role of the National Cancer Institute (NCI) was also raised in this context.

I certainly understand why everyone focused on the role of the FDA: they are the most visible opponents when patients try to exercise their inalienable right to pursue innovative treatments for otherwise incurable illnesses. I was absolutely horrified as I listened to the agony of patients who were blocked from receiving the treatments of their choice by a cold and insensitive FDA bureaucracy. And so there is no doubt in my mind that FDA needs serious reform.

However, as odd as it may sound, in my opinion, the principal roadblock right now is not FDA, not the American Medical Association, not the American Cancer Society, not Memorial Sloan-Kettering or the other comprehensive cancer centers.

I think the main problem presently resides at the NCI.

And not NCI as a whole, either. It is a small group of bureaucrats at NCI, closely tied to the chemotherapy approach, who are desperately afraid to allow the fair testing of even a single alternative treatment.

Their personal motivations are unknown. However, to me it seems obvious that if a single non-toxic treatment is tested, found beneficial, and then approved, this will open the floodgates to the approval and use of many such treatments. This will break the virtual monopoly that chemotherapy now holds on the systemic treatment of cancer.

Let's face it: chemotherapy is an extremely unpopular type of medicine. It is also notoriously ineffective for the vast majority of situations in which it is given. Therefore, the approval of a new type of anticancer treatment, such as anticancer diets or non-toxic immune boosters, would seriously undermine the rampant over-medication of cancer patients with cytotoxic drugs.

Yet we know that this over-medication is the basis of the double digit growth of the cancer drug industry, whose international sales now total $14 billion per year.

EVERYTHING COMES DOWN TO POMES

In my testimony to Rep. Burton's committee, I made a conscious decision to focus Congressional attention on what, at first sight, might seem like a rather obscure question. This is the Practice Outcomes Monitoring and Evaluation System (POMES). We have written about this elsewhere.

AND WHAT IS POMES?

Many people ask us, "What is POMES?" Basically, POMES is a process by which alternative and complementary treatments for cancer could be tested in a fair and impartial manner. It would appoint an Oversight Board, which would be made up of prominent and trustworthy representatives from both orthodox and alternative medicine. This Board would have the last word on whether or not a clinical trial was being performed fairly .

POMES was initiated by the National Cancer Institute in partnership with the Office of Alternative Medicine. But NCI has so far refused to move forward with the "POMES Process." They seem to be frozen in their tracks. It may take an act of Congress to get them to agree to test treatments coming from outside orthodox American oncology.

The POMES initiative was launched with a meeting at NIH in August, 1997 of 100 international experts. It was jointly sponsored by the NCI and the Office of Alternative Medicine (OAM). Since that time, however, we participants have heard absolutely nothing about POMES. Apparently, the $200,000 spent on the meeting was a complete waste. Many participants simply assumed it died a natural death.

In fact, there has been intense in-fighting over this question at the NIH itself. And, believe me, the problem does not reside with the Office of Alternative Medicine, which co-convened (and funded) the meeting with NCI. We believe that NIH Director Harold Varmus and NIH Deputy Director Ruth Kirschstein are in favor of moving the POMES process forward.

The problem resides squarely at NCI. There appear to be two powerful factions at work, each headed by people with enormous clout within the government health bureaucracy. One part of NCI favors moving forward with POMES. The others refuse to budge, place obstacles in the path of this initiative, and basically take the stance that they have no interest in alternative treatments and do not think NCI should be involved in this.

Yet there are many indications that the public is intensely interested in getting scientific evidence on the safety and efficacy of the leading complementary approaches to cancer. In fact, nearly 70 percent of the inquiries that come in to the OAM concern alternative and complementary approaches to cancer. Most of the scientific community also supports investigations of such methods. POMES participants already include the director of a comprehensive cancer center, two department chairmen from Memorial Sloan-Kettering, the vice presidents for R&D of "Fortune 500" corporations, the head of a large health foundation, etc. Not to mention the support of the entire alternative cancer community.

WHERE'S KLAUSNER?

Yet NCI refuses to move on this. And where does its Director Richard Klausner stand on all this? Somewhere in the middle. He approved the POMES meeting, contributed $100,000 to it and was briefed on its outcome by high officials of his institute. Yet he seems strangely detached from the nitty gritty details, allocating that duty to others. Perhaps he feels out of his element in dealing with this issue. We recall that Dr. Klausner was a relatively obscure scientist who was rather unexpectedly chosen for the post of director of one of the nation's largest scientific agencies. He is not a cancer insider, but was brought in to mildly reform an agency that was plagued by disaffection and by defections of top scientists to higher paying jobs in industry. (His predecessor, Samuel Broder, MD, left to take a high-paying job with IVAX pharmaceuticals.) [See Ralph Moss's open letter to Dr. Klausner on POMES. But also see our letter to colleagues on the big changes underway at NCI.]

Yet each day that goes by without a positive decision leaves NCI increasing isolated in its unbending opposition to alternative medicine. MSKCC, once a hotbed of "quackbusting," is rapidly setting up a complementary medicine center. The ACS has pulled back all of its derogatory statements on "unproven" treatments. Its current president and at least one past president will be participating in the June, 1998 cancer conference organized by the Center for Mind-Body Medicine. The latest "defection" is the American Medical Association, which recently declared alternative medicine the second most important story of 1998, and whose journal (JAMA) is about to feature special issues on alternative, complementary and integrative medicine.

READING NCI'S MIND

When the Burton Hearings happened, NCI was just about to make up its mind about POMES--whether to participate in the process of fair evaluation of alternative and complementary cancer treatments. To the layperson, this might seem like a "no-brainer." Who in their right mind would be against fair and impartial testing of such methods?

But NCI's anti-POMES faction is isolated from public opinion. If I can attempt for a moment to read their minds, I would say it goes something like this:

"Fair testing of such methods sounds good. But the creation of an independent Oversight Board will mean an end of a long era in which NCI itself has been "judge, jury and executioner" of these methods. It means that we will no longer be able to "declare" a method worthless without doing clinical trials (as happened in the case of Krebiozen), no longer be able to "ignore" positive animal data (as happen with laetrile) and no longer be able to arbitrarily change the protocols of trials without the agreement of the practitioner (as happened in the case of Burzynski). In other words, it means a loss of our unbridled power over this sphere of testing. I vote no."

ENTER THE CONGRESS

My guess is that NCI was about to announce the termination of POMES, with some trumped up statement about the need for better allocation of scare resources, etc. (That's what public relations departments are for.) But at this critical moment, Rep. Dan Burton stepped forward as a defender of patients' right to choose among a broad spectrum of treatments.

The Committee on Government Reform and Oversight is uniquely well situation do do so. "Reform" is its middle name! Burton's committee has oversight over the entire government, including NCI and FDA. And he intends to use that power.

He therefore decided to hold hearings about access to medical treatments for patients with dire diseases like cancer. The focus of the hearings was understandably the FDA. But I used my testimony at least to raise the important issue of POMES and the role of the NCI.

POMES is so important because the whole justification not to allow alternative treatments comes down to the fact that they are "unproven methods." They are charged with not being scientifically evaluated, much less approved by FDA. And in many cases, this is technically true. But why is this? The cancer establishment would have you believe that proponents of such methods are money-hungry frauds, trying to do an end run around good science and proper regulation.

So I say, let's stop the name calling and DO the good science. That way we all will know if alternative treatment A is worthless or possibly better than chemotherapy treatment B. But as long as NCI can block such testing they can claim these are "unproven methods."

TEST THEM NOW!

We say, test them now! Put at least $20 million into a serious effort to examine the most prominent and promising treatments. If they fail, that's fine also, since this will help prevent patients from wasting their time and money on useless treatments. (And logic tells us that there are some useless alternative treatments out there.)

But if some prove worthwhile, then these should be subjected to further testing, then approved, implemented and used. POMES and its Oversight Board are inevitable, indispensable and essential links in this process. We do NOT want a repeat of the fiascos that surrounded the "testing" of Krebiozen, laetrile, hydrazine sulfate or Burzynski. The Oversight Board must contain prominent critics of the NCI, defenders of freedom of choice, as well fair members of the conventional medical/scientific community. It must be unimpeachable in its knowledge, honesty and goodwill. Its "Good Housekeeping seal" will be believed, whether the results turn out negative or positive.

'SIC' ME ON THEM?

I believe this is now the perspective of Rep. Burton and many other members of Congress. We also believed Rep. Burton when he told us that if NCI doesn't respond to his concerns over POMES, "we will sic you [i.e., RWM] on them." It was the first time in my life that I have been compared to a dog--and enjoyed it! Frankly, I would enjoy the opportunity to confront the top officials of the NCI--under oath--before a powerful Congressional committee.

I am hopeful that Rep. Burton will follow through promptly and send a sharply worded letter to Director Klausner, demanding to know what happened to POMES. I wouldn't be surprised if such a letter had the desired effect and that in a very short time we shall hear that NCI is moving forward with the POMES process.

If not, we shall have a protracted period of struggle ahead of us, simply to get promising cancer treatments tested fairly by an agency that commands $2.2 billion of U.S. taxpayer dollars.

--Ralph W. Moss, Ph.D., 2/7/98 (revised 2/8, 2/10 , 2/13 and 2/26/98)



Article on Hearings

Testimony

Big Changes at NCI

 


Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.



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